Marijuana Research Hampered by Access from Gov.

Mar 24, 2014

Mil­lions of ordi­nary Amer­i­cans are now able to walk into a mar­i­juana dis­pen­sary and pur­chase bags of pot on the spot for a vari­ety of med­ical ail­ments. But if you’re a researcher like Sue Sis­ley, a psy­chi­a­trist who stud­ies post trau­matic stress dis­or­der, get­ting access to the drug isn’t nearly so easy. That’s because the fed­eral gov­ern­ment has a vir­tual monop­oly on grow­ing and cul­ti­vat­ing mar­i­juana for sci­en­tific research, and get­ting access to the drug requires three sep­a­rate lev­els of approval. Mar­i­juana offers hope for 6-year-old girl with rare condition: In mar­i­juana, Lydia Schaeffer’s fam­ily mem­bers think they might have found a treat­ment that works. Now, they are try­ing to help legal­ize the drug. Sisley’s fight to get sam­ples for her study — now in its fourth month — illu­mi­nates the com­plex pol­i­tics of mar­i­juana in the United States. While 20 states and the Dis­trict have made med­ical mar­i­juana legal — in Col­orado and Wash­ing­ton state the drug is also legal for recre­ational use — it remains among the most tightly con­trolled sub­stances under fed­eral law. For sci­en­tists, that means extra steps to obtain, trans­port and secure the drug — delays they say can slow down their research by months or even years. The bar­ri­ers exist despite the fact that the num­ber of peo­ple using mar­i­juana legally for med­ical rea­sons is esti­mated at more than 1 mil­lion. Stalled for decades because of the stigma asso­ci­ated with the drug, lack of fund­ing and legal issues, research into marijuana’s poten­tial for treat­ing dis­eases is draw­ing renewed inter­est. Recent stud­ies and anec­do­tal sto­ries have pro­vided hope that mar­i­juana, or some com­po­nents of the plant, may have diverse appli­ca­tions, such as treat­ing can­cer, HIV and Alzheimer’s dis­ease. But sci­en­tists say they are frus­trated that the fed­eral gov­ern­ment has not made any efforts to speed the process of research. Over the years, the Drug Enforce­ment Agency has turned down sev­eral peti­tions to reclas­sify cannabis, reit­er­at­ing its posi­tion that mar­i­juana has no accepted med­ical use and remains a dan­ger­ous drug. The DEA has said that there is a lack of safety data and that the drug has a high poten­tial for abuse. Sisley’s study got the green light from the Food and Drug Admin­is­tra­tion in 2011, and for most stud­ies, that would have been enough. But because the study is about mar­i­juana, Sis­ley faced two addi­tional hur­dles. First, she had to apply to the Depart­ment of Health and Human Ser­vices to pur­chase ­research-grade sam­ples from the one farm in the United States — housed at the Uni­ver­sity of Mis­sis­sippi and man­aged by the National Insti­tute on Drug Abuse — that is allowed to grow mar­i­juana under fed­eral law. HHS ini­tially denied her appli­ca­tion but then approved a revised ver­sion March 14 — more than four months after it was sub­mit­ted. Now, Sis­ley must get per­mis­sion from the DEA to pos­sess and trans­port the drug. Spokes­woman Dawn Dear­den said that the agency is sup­port­ive of med­ical research on mar­i­juana but needs to fol­low reg­u­la­tions under the Con­trolled Sub­stances Act. “DEA has not denied DEA reg­is­tra­tion to a HHS-approved mar­i­juana study in the last 20-plus years,” she said. Sis­ley, who began her work with PTSD while at the Depart­ment of Vet­er­ans Affairs and now works at the Uni­ver­sity of Ari­zona Col­lege of Med­i­cine, says she con­sid­ers the HHS news a “tri­umph” for mar­i­juana research. But she says the study has “a poten­tially long road with the DEA who is famous for delays.” “There is a des­per­ate need for this research, but it’s impos­si­ble to study this drug prop­erly in an atmos­phere of pro­hi­bi­tion,” she said. Orrin Devin­sky, direc­tor of the epilepsy cen­ter at New York University’s Lan­gone Med­ical Cen­ter, said many would-be mar­i­juana researchers are dri­ven to aban­don projects after they dis­cover how time-consuming and expen­sive it can be to obtain the drug. “There is no ratio­nale for this except for the fed­eral government’s out­dated 1930s view about mar­i­juana,” said Devin­sky, who is study­ing the use of an extract of the plant for the con­trol of seizures. A Resur­gence in Research The cannabis plant was once a sta­ple in Amer­i­can phar­ma­cies, but since the turn of the 20th cen­tury, some states began to see it as a poi­son and intro­duced restric­tions. Research on its med­i­c­i­nal uses came to a vir­tual stand­still. There are now 156 active researchers who are approved by the DEA to study mar­i­juana — a num­ber that has remained steady in recent years — but sci­en­tists say most are government-funded and focus on the ill effects of smok­ing mar­i­juana rather than on poten­tial med­i­cines. That’s poised to rad­i­cally change. As an increas­ing num­ber of states have legal­ized the use of med­ical mar­i­juana, a bustling indus­try of start-up drug com­pa­nies and med­ical groups focused on find­ing marijuana-based treat­ments has emerged. GW Phar­ma­ceu­ti­cals, a British com­pany, is study­ing two dif­fer­ent extracts of mar­i­juana that have shown promise for patients with Type 2 dia­betes and epilepsy. ISA Sci­en­tific, based in Utah, is research­ing med­ica­tions for pain and dia­betes made from the cannabi­noids found in mar­i­juana that could be swal­lowed in cap­sule form. Some of these new-generation researchers are explor­ing ways to try to speed up their work by bypass­ing the fed­eral process for obtain­ing the drug. In Col­orado, for instance, aca­d­e­mic researchers have asked state offi­cials whether they would allow them to study extracts grown within the state. In Geor­gia, sci­en­tists are seek­ing leg­isla­tive action to allow the state’s five med­ical research uni­ver­si­ties to cul­ti­vate mar­i­juana. A bill allow­ing them to do so recently won the back­ing of a House com­mit­tee. Much of the debate sur­round­ing mar­i­juana research is focused on its clas­si­fi­ca­tion by the DEA as a Sched­ule I drug, the most restric­tive of five cat­e­gories. Sched­ule I drugs are con­sid­ered to have a high poten­tial for abuse and no accepted med­ical use. Other drugs in that group include LSD, heroin and ecstasy. The Amer­i­can Med­ical Asso­ci­a­tion said in Novem­ber that it does not sup­port state med­ical mar­i­juana efforts and still con­sid­ers the drug dan­ger­ous. But it also called on the gov­ern­ment to encour­age more clin­i­cal research — by recon­sid­er­ing its clas­si­fi­ca­tion as a Sched­ule I drug. A lower-level clas­si­fi­ca­tion would allow researchers to obtain mar­i­juana more eas­ily. The fact that the Obama admin­is­tra­tion in recent months has moved to loosen restric­tions on mar­i­juana in other regards has raised hopes that it will take sim­i­lar action that will help sci­en­tists. The Jus­tice Depart­ment said last year that it would not chal­lenge state laws legal­iz­ing mar­i­juana, and in Feb­ru­ary, the Trea­sury announced new guide­lines meant to make it eas­ier for cannabis busi­nesses to open bank accounts in states where the drug is legal. Kevin Sabet, a for­mer White House senior adviser for drug pol­icy who has been dubbed the No. 1 legal­iza­tion enemy by Rolling Stone mag­a­zine, said he sup­ports efforts to break down bar­ri­ers for researchers. But he pro­posed that this could be done more effi­ciently with­out resched­ul­ing the drug — which remains highly con­tro­ver­sial and would have impli­ca­tions for the crim­i­nal jus­tice sys­tem. Sabet signed a let­ter sent this month to senior admin­is­tra­tion offi­cials by a coali­tion of peo­ple work­ing in drug pre­ven­tion and related causes. The let­ter sug­gested that the DEA could instruct field offices to process appli­ca­tions with­out delay after FDA approval and could relax stor­age require­ments for the com­po­nents of mar­i­juana used in the con­text of an inves­ti­ga­tional new drug. ‘The Whole Process is Wrong’ In the brave new world of med­ical mar­i­juana, fam­ily doc­tors, psy­chi­a­trists and other com­mu­nity prac­ti­tion­ers are the gate­keep­ers and must deter­mine whether a patient truly needs the drug. But in many cases, doc­tors are pre­scrib­ing the drug for their patients against the rec­om­men­da­tions of med­ical soci­eties and with only lim­ited research to back up what they are doing. “The whole process is wrong,” said Andrew Weil, the Amer­i­can doc­tor and author who con­ducted the first double-blind clin­i­cal tri­als of mar­i­juana in 1968. “There is a great deal of evi­dence both clin­i­cal and anec­do­tal of its ther­a­peu­tic effects, but the research has been set way back by gov­ern­ment polices,” Weil added. “We are at the point where we are really just learn­ing about this, and for doc­tors that means a lot of exper­i­men­ta­tion,” said Bon­nie Gold­stein, a pedi­a­tri­cian who is med­ical direc­tor of the Ghost Group, which man­ages WeedMaps​.com, a search­able direc­tory of doc­tors and dis­pen­saries. In many states, for instance, mar­i­juana is approved for pain and pre­scribed for those with arthri­tis. But a study pub­lished in the jour­nal of the Amer­i­can Col­lege of Rheuma­tol­ogy this month found that the effec­tive­ness and safety of mar­i­juana to treat con­di­tions such as arthri­tis are not sup­ported by med­ical evi­dence. Another con­di­tion for which med­ical mar­i­juana is widely pre­scribed is PTSD. Yet the Amer­i­can Psy­chi­atric Asso­ci­a­tion dis­cour­ages doc­tors from using it to treat psy­chi­atric dis­or­ders. In a state­ment in Novem­ber, the APA said, “There is no cur­rent sci­en­tific evi­dence that mar­i­juana is in any way ben­e­fi­cial for the treat­ment of any psy­chi­atric dis­or­der.” Sis­ley said she has been work­ing with mar­i­juana for sev­eral years to treat sol­diers return­ing from Afghanistan and Iraq who have flash­backs, insom­nia and anx­i­ety, but she has had ques­tions about dosages that haven’t been answered. Is one gram a day opti­mal? Or two? Is it bet­ter to smoke the mar­i­juana or use a vapor­izer, which heats ground mar­i­juana leaves to pro­duce a gas? Sis­ley — who is work­ing on the PTSD study with Rick Doblin, a psy­chol­o­gist and exec­u­tive direc­tor of the Mul­ti­dis­ci­pli­nary Asso­ci­a­tion for Psy­che­delic Stud­ies — says she thinks the next big polit­i­cal fight over mar­i­juana may come from stud­ies such as hers. If research shows that mar­i­juana is an effec­tive med­ical treat­ment, it could force the fed­eral government’s hand on reclas­si­fy­ing it. Source: Wash­ing­ton Post (DC) Author: Ari­ana Eun­jung Cha Pub­lished: March 21, 2014 Copy­right: 2014 Wash­ing­ton Post Com­pany Con­tact: letters@​washpost.​com Web­site: http://​www​.wash​ing​ton​post​.com/

45607bba69rtweed1.jpg1 150x115 Marijuana Research Hampered by Access from Gov.

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